MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES DISPERSION AORTIC PERFUSION CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number DCT21TA

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Arterial and venous cannulae are used to divert large volumes of blood from the heart to the cardiopulmonary bypass machine during cardiac surgery procedures.A disruption of that circuit may pose a significant risk for patient injury, which is not remote.A partial or complete cannula separation may require an exchange of the cannula which results in a temporary interruption of bypass.A cannula exchange may result in cardiovascular failure, ischemic events or significant blood loss.Cannula malfunctions that do not allow, or have the potential (before use) to not allow the cannula to maintain an uninterrupted, unobstructed large extracorporeal blood volume circulation, might cause serious injury or death.The device was returned and the product evaluation is in process.The root cause of this event cannot be conclusively determined at this time.A supplemental mdr will be submitted once the evaluation is completed.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Udi number: (b)(4).

Event Description

It was reported that the angle of the luer connector to the cannula was found to be different than usual before use of the device.The customer opened the device package and noticed the issue during preparation of the device.The device was replaced.There were no patient complications reported.It is unknown if there was any separation between the cannula and the connector, however, the connector was attached to the cannula at an angle of about 90 degrees different from the normal device.

Event Description

It was reported that the angle of the luer connector to the cannula was different from usual before use.The customer opened the package and noticed it during preparation.The device was replaced.The device will be returned for evaluation.There were no patient complications reported.It is unknown if there is any separation between the cannula and the connector, however the connector was attached to cannula at an angle of about 90 degrees different from the normal device.

Manufacturer Narrative

Updated sections b5 and h3 per new information received.H3: product evaluation customer report of "angle of the luer connector to the cannula was different from usual" was not confirmed.As received, the cannula body was connected to the t-connector.No other visual damage, contamination, or other abnormalities were found.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated h3 and h6 per new information received.H3: updated product evaluation.Customer report of "angle of the luer connector to the cannula was different from usual" was confirmed.As received, the cannula body was connected to the t-connector.Upon closer inspection, it seems as if the dispersion tip is just slightly bent away from the orientation line.No other visual damage, contamination, or other abnormalities were found.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES DISPERSION AORTIC PERFUSION CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9469535
• MDR Text Key: 207056891
• Report Number: 3008500478-2019-00178
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Model Number: DCT21TA
• Device Catalogue Number: DCT21TA
• Device Lot Number: 60784438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 01/19/2020; 02/05/2020; 07/23/2020
• Supplement Dates FDA Received: 02/01/2020; 02/19/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1